Phase 2 Study of Ex-vivo Perfusion and Ventilation of Lungs to Assess Transplant Suitability

Summary

The purpose of this research study is to perfect the technique of EVLP and learn about the safety of transplanting lungs that have been ventilated (attached to a breathing machine or ventilator to deliver oxygen) and perfused with a lung perfusion solution (Steen solution™, made by Vitrolife). This ventilation and perfusion will be done outside the body (ex-vivo) in a modified cardiopulmonary bypass circuit (the kind of device used routinely during most heart surgeries). The purpose of performing ex-vivo lung perfusion and ventilation (EVLP) is to learn how well the lungs work, and whether they are likely safe to transplant.

Conditions

• Emphysema
• Chronic Obstructive Pulmonary Disease (COPD)
• Cystic Fibrosis
• Pulmonary Fibrosis
• Bronchiectasis
• Sarcoidosis
• Pulmonary Hypertension
• Alpha-1 Antitrypsin Deficiency

Interventions

DEVICE

Steen Solution™

This solution is a buffered dextran and albumin-containing extracellular perfusate with an optimal colloid osmotic pressure developed specifically for extra-corporeal perfusion of lungs. After EVLP, lungs will be cooled in the circuit to room temperature, then flushed with cold Perfadex™ and taken to UNC Hospitals (UNCH) where they will have an ex-vivo CT scan. Lungs determined suitable will be offered to consented patients at UNCH based on Lung Allocation Score. Lungs not considered for transplantation may be subjected to different experiments but are not to be a part of this research study. In summary, lungs with good and stable function during EVLP with Steen Solution™ will be transplanted into recipients as per current clinical practice.

OTHER

Conventional Lung Transplant

No experimental procedures will be carried out. Lungs from conventional brain-dead organ donors will be used for transplant.

Sponsors & Collaborators

• Vitrolife

  collaborator INDUSTRY

• XVIVO Perfusion

  collaborator INDUSTRY

• University of North Carolina, Chapel Hill

  lead OTHER

Principal Investigators

• Thomas M. Egan, MD, MSc. · UNC-Chapel Hill

Study Design

Allocation

NON_RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-12-31

Primary Completion

2012-12-31

Completion

2013-03-31

FDA Device

Yes

Countries

• United States

Study Locations